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The use of venetoclax-based therapies for pediatric patients with relapsed or refractory malignancies is increasingly common outside of the clinical trial setting. For patients who cannot swallow tablets, it is common to crush the tablets and dissolve them in liquid to create a solution. However, no PK data exists in adults or children using crushed tablets dissolved in liquid in this manner, and as a result, the venetoclax exposure with this solution is unknown.
Primary Objectives
• To determine the pharmacokinetics of venetoclax when commercially available tablets are crushed and dissolved into a solution
Secondary Objectives
Peripheral blood will be drawn at multiple time points to evaluate venetoclax pharmacokinetics in patients who are receiving venetoclax solution made from crushed tablets as part of their oncology treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children and Young Adults | Children and Young Adults who are prescribed venetoclax made from crushed tablets as part of their clinical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1. Drug: The Venetoclax PK study is collecting bodily fluid samples (ie., whole blood and optional cerebrospinal fluid) of patients prescribed venetoclax as crushed tablets per standard of care. | Other | Participants will receive Venetoclax as prescribed by their treating provider as part of their clinical care. |
| Measure | Description | Time Frame |
|---|---|---|
| Clearance (CL) as measured by PK sampling (Peripheral Blood; Required) | PK parameters of venetoclax will be described in peripheral blood including: the observed peak plasma concentration (Cmax) | Blood will be collected on one PK day between Days 5-12 after completion of the venetoclax dose ramp-up : within 1hr prior to the administration of venetoclax, then 2hrs, 5hrs, 12hrs, 18hrs and 24hrs after the administration of venetoclax. |
| Clearance (CL) as measured by PK sampling (Peripheral Blood; Required) | PK parameters of venetoclax will be described in peripheral blood including: the time to peak (Tmax) | Blood will be collected on one PK day between Days 5-12 after completion of the venetoclax dose ramp-up : within 1hr prior to the administration of venetoclax, then 2hrs, 5hrs, 12hrs, 18hrs and 24hrs after the administration of venetoclax. |
| Clearance (CL) as measured by PK sampling (Peripheral Blood; Required) | PK parameters of venetoclax will be described in peripheral blood including: the apparent terminal phase elimination rate constant (β) | Blood will be collected on one PK day between Days 5-12 after completion of the venetoclax dose ramp-up : within 1hr prior to the administration of venetoclax, then 2hrs, 5hrs, 12hrs, 18hrs and 24hrs after the administration of venetoclax. |
| Clearance (CL) as measured by PK sampling (Peripheral Blood; Required) | PK parameters of venetoclax will be described in peripheral blood including: the terminal-phase elimination half-life (T1/2) | Blood will be collected on one PK day between Days 5-12 after completion of the venetoclax dose ramp-up : within 1hr prior to the administration of venetoclax, then 2hrs, 5hrs, 12hrs, 18hrs and 24hrs after the administration of venetoclax. |
| Clearance (CL) as measured by PK sampling (Peripheral Blood; Required) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients must be receiving any dose of venetoclax given as a solution made from crushed tablets by mouth (PO) or via nasogastric (NG), or G-tube as prescribed by their treating oncologist.
Patients must be <39 years of age at time of study enrollment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Site Public Contact | Contact | (513) 636-2799 | cancer@cchmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Lauren Pommert, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
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Blood (1-2 mL) collected from an existing venous or arterial access line. Patients < 14 kg (approximately 31 pounds) will be limited to 1 mL for each PK sample draw.
OPTIONAL: An additional 3-4 mLs of cerebrospinal fluid (CSF) at any time point in which cerebrospinal fluid (CSF) is already being obtained as part of standard of care therapy.
|
PK parameters of venetoclax will be described in peripheral blood including: the areas under plasma concentration curve (AUC) over a 24-hour dose interval (AUC0-24) or for infinite time (AUC0-∞) |
| Blood will be collected on one PK day between Days 5-12 after completion of the venetoclax dose ramp-up : within 1hr prior to the administration of venetoclax, then 2hrs, 5hrs, 12hrs, 18hrs and 24hrs after the administration of venetoclax. |
| Clearance (CL) as measured by PK sampling (Peripheral Blood; Required) | PK parameters of venetoclax will be described in peripheral blood including: oral clearance (CL/F) of venetoclax | Blood will be collected on one PK day between Days 5-12 after completion of the venetoclax dose ramp-up : within 1hr prior to the administration of venetoclax, then 2hrs, 5hrs, 12hrs, 18hrs and 24hrs after the administration of venetoclax. |
| Clearance (CL) as measured by PK sampling (Cerebrospinal Fluid; Optional) | PK parameters of venetoclax will be described in cerebral spinal fluid including: the observed peak plasma concentration (Cmax) | Around Days 8, 15, 22, and/or 28, all +/- 3 days. Not all patients will have CSF collected at these time points. |
| Clearance (CL) as measured by PK sampling (Cerebrospinal Fluid; Optional) | PK parameters of venetoclax will be described in cerebral spinal fluid including: the time to peak (Tmax) | Around Days 8, 15, 22, and/or 28, all +/- 3 days. Not all patients will have CSF collected at these time points. |
| Clearance (CL) as measured by PK sampling (Cerebrospinal Fluid; Optional) | PK parameters of venetoclax will be described in cerebral spinal fluid including: the apparent terminal phase elimination rate constant (β) | Around Days 8, 15, 22, and/or 28, all +/- 3 days. Not all patients will have CSF collected at these time points. |
| Clearance (CL) as measured by PK sampling (Cerebrospinal Fluid; Optional) | PK parameters of venetoclax will be described in cerebral spinal fluid including: the terminal-phase elimination half-life (T1/2) | Around Days 8, 15, 22, and/or 28, all +/- 3 days. Not all patients will have CSF collected at these time points. |
| Clearance (CL) as measured by PK sampling (Cerebrospinal Fluid; Optional) | PK parameters of venetoclax will be described in cerebral spinal fluid including: the areas under plasma concentration curve (AUC) over a 24-hour dose interval (AUC0-24) or for infinite time (AUC0-∞) | Around Days 8, 15, 22, and/or 28, all +/- 3 days. Not all patients will have CSF collected at these time points. |
| Clearance (CL) as measured by PK sampling (Cerebrospinal Fluid; Optional) | PK parameters of venetoclax will be described in cerebral spinal fluid including: oral clearance (CL/F) | Around Days 8, 15, 22, and/or 28, all +/- 3 days. Not all patients will have CSF collected at these time points. |
| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital of Philadelphia | Not yet recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| Texas Children's Hospital | Recruiting | Houston | Texas | 77030 | United States |
|
| Children's Hospital of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
|
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D009196 | Myeloproliferative Disorders |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| D002051 | Burkitt Lymphoma |
| D016399 | Lymphoma, T-Cell |
| D016393 | Lymphoma, B-Cell |
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007951 | Leukemia, Myeloid |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
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